An MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
6. NONCONFORMING PRODUCT
The requirements of subpart I regarding nonconforming product incorporate the reprocessing requirements of the 1978 GMP regulation (820.115 and 820.116), but also add new ones. The term reprocessing has been replaced with the term rework, which is defined as "action taken on a nonconforming product so that it will fulfill the specified DMR [device master record] requirements before it is released for distribution" (820.3(x)). One distinction between the reprocessing requirements of the 1978 regulation and those in the final rule is that the effect of reprocessing must be known, even if the reprocessing is not repeated. The 1978 regulation only required a determination of the effect of reprocessing when there was "repeated reprocessing."
Another significant change made in the requirements of this section since the 1995 working draft was published is that the wording no longer suggests that all nonconformances be investigated, which would have been a major burden for most manufacturers. Instead, the requirements now state that the evaluation of a nonconformance shall include a determination of the "need for" an investigation. Therefore, a manufacturer's nonconforming product procedures should provide a means for determining when an investigation is necessary.
Another change in this section of the final regulation is that the manufacturerÕs procedures are no longer required to provide for the identification, documentation, evaluation, segregation, and disposition of nonconforming products. The new rule says only that the manufacturer's procedures must address these activities, thus providing flexibility that will allow manufacturers to define how they will control nonconforming products.
